Quality Control Lead Scientist

Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report.

The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu. The School of Medicine has recently completed construction on a new GMP Good Manufacturing Practice) Facility). Our facility is a production facility for the manufacturing of cellular and gene therapy products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control laboratory and quality assurance department, to control collection, processing, storage, and release of cell therapy products.

At UCI, the GMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory. Your Role on the Team Reporting to GMP Manager the QC lead scientist will oversee the analytical development and quality control (QC) activities to ensure GMP compliance for UCI GMP facility products.

Establish and perform in-house assays for product release. Lead and perform a variety of QC functions in support of the GMP facility. QC testing will vary for each project based on the type of cells, tissues, or organs.

Lead and perform a broad range of tissue culture and microbiological methods, utilizing good aseptic techniques and lab practices in support of for developing, processing, and manufacturing both research and clinical grade cellular products in accordance to established standard operating procedures (SOP). Lead and perform cellular, micro and molecular biology procedures including but not limited to Western blot, Northern blot, Polymerase chain reaction (PCR), Flow cytometry (Staining: intracellular and surface, Acquisition and Analysis), Gene expression analysis, DNA and RNA processing and Mammalian cell culture. Lead environmental monitoring (EM), QC analysis, provide technical oversite and complete routine record review of test data and related GMP documents under moderate supervision. Must also have the ability to perform statistical analysis to generate trend reports on environmental monitoring and product release data, be knowledgeable in molecular biology techniques including mRNA, DNA extraction and RT-PCR.

Will conduct investigations regarding EM action level excursions and out of specification (OOS) results for any QC tests executed within the GMP facility or by external laboratories. Interact with internal and external testing service providers to ensure quality, and review and approve third-party assays. Additionally, the QC lead scientist will recruit, manage, and train QC staff for tasks in a cGMP facility.

Review, revise, and develop standard operating procedures (SOPs) as needed. Maintain up-to-date knowledge of regulatory requirements, lab technologies, and attend relevant training and conferences. Maintain complete documentation as required by Federal law (21CFR 210 and 211) and adhere to Standard Operating Procedures (SOPs). Prepare and properly store all incoming, intermediate, and final products, apply appropriate labels to incoming and outgoing products and monitor for proper product labels and handling during QC testing.

Perform incoming product, in process and final product quality control tests and maintain complete documentation throughout the manufacturing process. Adhere to maintenance schedules and schedules preventive maintenance, troubleshoot malfunctions and report problems, repairs critical parts of equipment (such as media and fluid pumps, centrifuge, autoclave issues, etc.) designated for certain manufacturing processes and resolve unscheduled maintenance problems. Ensure that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced.

Ensure that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs. Ensure the work areas are kept clean, neat and orderly as needed for GMP compliance and supply inventory is maintained at appropriate levels.  What It Takes to be Successful Total Compensation In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding.

These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits. Required: Academic background and experience in relevant area of research.

Ability to build relationships, collaborate and problem solve both internally and with external organizations. Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders. Demonstrated knowledge university, state, and federal policies that influence higher education.

Familiarity with regulatory affairs, quality control and production. Quality Control Assays Experience (e.g., qPCR, Flow Cytometry, Elisa, etc.). Development, optimization, and validation of analytical assays. Experience with maintenance of analytical and retain sample inventory logs under GMP compliance.

Development, optimization, and validation of analytical assays. Master's or PhD in molecular biology, microbiology, biochemistry, or related science/engineering field required. Ph.D. in life science, biochemistry or equivalent.

Prior experience working in an aseptic environment, biosafety cabinet and working with human tissues required. 2+ years of aseptic cell culture (human primary cells and/or human cell lines) is required. 1-year General knowledge of GMP and GLP procedures. 2+ years Flow Cytometry (staining, acquisition, and analysis). Preferred: Demonstrated experience supervising staff and students in an academic or research setting. Demonstrated knowledge of program development as well as grant proposal development and administration.

Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution. Knowledge of human resources management practices and policies. Knowledge of financial principles and budget practices.

Experience in writing SOPs and Batch Record. Environmental Monitoring Testing. Experience in stability testing and environmental monitoring.

Special Conditions: Must be able to work safely with chemicals and hazardous materials. Must be able to work overtime and flexible shifts.

Must be able to perform daily facility operation. Conditions of Employment: The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community.

As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment: Background Check and Live Scan Legal Right to work in the United States Vaccination Policies Smoking and Tobacco Policy Drug Free Environment The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements. California Child Abuse and Neglect Reporting Act E-Verify Pre-Placement Health Evaluation Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php Closing Statement:

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20.

For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination. We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu. Consideration for Work Authorization Sponsorship Must be able to provide proof of work authorization